This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Device | SOFT MATE(R) DW (HEFILICON A) CONTACT LENS |
Generic Name | Sterilizer, Soft-lens, Thermal, Ac-powered |
Applicant | WESLEY JESSEN CORP. |
Date Received | 1983-12-20 |
Decision Date | 1984-04-16 |
PMA | N17367 |
Supplement | S012 |
Product Code | HRD |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903 |
Supplement Number | Date | Supplement Type |
---|---|---|
N17367 | Original Filing | |
S013 | 1985-03-04 | |
S012 | 1983-12-20 | |
S011 | 1983-11-14 | |
S010 | ||
S009 | 1980-02-05 | |
S008 | ||
S007 | ||
S006 | ||
S005 | 1974-10-01 | |
S004 | ||
S003 | ||
S002 | ||
S001 | 1979-02-06 |